(18 days)
The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.
The Medtronic® Zuma™ Guiding Catheters will be available in 5F 9F outer diameters. The 6F and 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (materials used) | "All appropriate Biocompatibility tests were successfully performed on the materials used for the Medtronic® Zuma™ Guiding Catheter." |
| Performance Specifications (applicable specifications, adequacy for intended use) | "Test results verified that the Medtronic® Zuma™ Guiding Catheters meet all of the applicable specifications and are deemed adequate for the intended use." |
| Substantial Equivalence (to predicate devices) | "The Zuma™ guide catheter is considered to be substantially equivalent to the following device: Medtronic® 6F Zuma™ Guiding Catheter, Medtronic® 7F. 8F Zuma™ Guiding Catheter, Medtronic® Vector™ X Guiding Catheter, Cordis® Brite Tip® Guiding Catheter." |
| Inner Lumen Diameter (for 6F-9F sizes) | "The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices." |
| Stiffness (for 5F size) | "The 5F Zuma is comparable in stiffness to a 6F predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not specify the sample size used for the test set or the data provenance. The document indicates that tests were performed ("Test results verified"), but there are no details on the number of catheters or samples tested, nor where the testing was conducted or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document refers generally to "Test results" and "specifications" for a medical device (guiding catheter), which typically involve engineering and material science testing, rather than human expert interpretation of data like images. Therefore, the concept of "experts" establishing ground truth in this context (for mechanical and material properties) is not directly applicable in the same way it would be for AI-powered diagnostic devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not typically relevant for the type of device (guiding catheter) or the nature of the testing described (biocompatibility, performance specifications of physical attributes). Adjudication methods are more commonly associated with human interpretation tasks or clinical endpoints requiring consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication of an MRMC comparative effectiveness study being conducted. This device is a guiding catheter, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical guiding catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance criteria mentioned (biocompatibility, inner lumen diameter, stiffness), the "ground truth" would be established by standardized laboratory testing procedures, physical measurements, and adherence to predefined material science and engineering specifications. For example, biocompatibility testing would follow ISO standards, diameter measurements would use precision instruments, and stiffness testing would involve specific mechanical test setups.
8. The sample size for the training set
This information is not applicable. This document describes the 510(k) submission for a physical medical device (guiding catheter), not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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3/22/99
510(k) Notification Medtronio® Zuma™ Guiding Catheter
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990)
- The trade or proprietary name of the device is the Medtronic® Zuma™ Guiding Catheter. The l . Medtronic® Zuma™ Guiding Catheter will be available in 5F- 9F sizes and in curve styles similar to the current Medtronic Guiding Catheters.
- The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which 2. therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
- The Medtronic® Zuma™ Guiding Catheters will be available in 5F 9F outer diameters. The 6F and 3. 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.
- All appropriate Biocompatibility tests were successfully performed on the materials used for the 4. Medtronic® Zuma™ Guiding Catheter.
- న్. Test results verified that the Medtronic® Zuma™ Ouiding Catheters meet all of the applicable specifications and are deemed adequate for the intended use. The Zuma™ guide catheter is considered to be substantially equivalent to the following device:
- Medtronic® 6F Zuma™ Guiding Catheter ●
- . Medtronic® 7F. 8F Zuma™ Guiding Catheter
- Medtronic® Vector™ X Guiding Catheter ●
- Cordis® Brite Tip® Guiding Catheter .
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 1999
Mr. Mark Chartier Quality Assurance and Regulatory Affairs Director Medtronic Interventional Vascular, Inc. 37A Cherry Hill Drive Danvers, MA 01923
Re: K990707 Medtronic® Zuma™ Guiding Catheter Trade Name: Requlatory Class: II Product Code: DQY Dated: March 3, 1999 Received: March 4, 1999
Dear Mr. Chartier:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerninq your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Mr. Mark Chartier
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594- Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: To be assigned by FDA K996707
Device Name:
Medtronic® Zuma™ Guiding Catheter
Indications for Use:
The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Victor Lam Hu
rdiovascular, Respiratory, 510(k) N
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).